Patient Safety

Thank you, Dr. Jessee (William F. Jessee, MD, President and CEO of the Medical Group Management Association). It's great to be here today at the National Patient Safety Congress. I also want to thank Carolyn Clancy (Director of the Agency for Healthcare Research and Quality) for being here. Isn't she a delight? Carolyn and I are very proud that the best employees in the federal government work at HHS.

The greatest health care system the world has ever known operates in the United States, and the people in this room are part of it. America's doctors and hospitals offer the best care because they enjoy the freedom to compete and Americans enjoy a choice of providers. Thanks to that competition, over the past thirty years, medical innovation and new technology have changed the face of health care and helped Americans to live longer and healthier lives.

President Bush and I share a vision for American health care-a vision in which physicians can focus on the quality of their care, not the quantity of their paperwork � a vision in which Americans have the freedom to get the care they need � and a vision in which doctors, administrators, and state and federal governments cooperate to build a healthier America.

We don't just share that vision, we also share a sense that this is the year we can turn the corner. This is the year we can work with Congress and states and the health care community and ordinary Americans to make the critical reforms in our policies, our procedures, and our lifestyles that will launch a new century of medical excellence and good health.

Over the past two years, through waivers and state plan amendments, my department has already expanded access to health coverage for more than 2.2 million people, and expanded the range of benefits offered to 6.7 million other Americans. We have proposed tax-based supports to help low-income Americans purchase health insurance. We have expanded community health centers. And we have proposed innovative programs to support the activity of faith-based and community health centers.

This morning, I would like to talk with you about a variety of steps we're taking to improve health care. Steps focused on doctors. Steps focused on medication. Steps focused on seniors. Steps focused on the poor. Step after step after step on a road to a healthier America.

Let me start by making some news. I am proud to announce today the next major step towards modernizing the patient safety system. The Food and Drug Administration is proposing two new rules to prevent errors with medication. The first of these proposals will require bar coding on almost all pharmaceuticals and blood products.

This rule would help reduce the number of medication errors by allowing health care professionals to use bar code scanning equipment to verify that the right drug in the right dose is given to the right patient at the right time. It would also require the use of machine-readable information on blood and blood component container labels to help prevent errors in the use of blood products.

These bar codes would be part of a quality control system, along with bar code scanners and computerized databases. The proposed rule would apply to manufacturers, re-packers, re-labelers, and private label distributors of prescription drugs and over-the-counter drugs used in the hospital. A patient would have his or her drug regimen information entered into a computerized database.

The label of each drug would have a bar code, a code that would provide unique identifying information about the drug that is to be dispensed to the patient, to help guard against conflicting treatments or other errors.

Medication errors are a serious public health problem, but they are also preventable. Using this bar code technology, we can prevent such errors as: administering the wrong dose of a drug, administering a drug that causes a known allergic reaction in the patient, administering the wrong drug to a patient, or administering the right drug at the wrong time.

The second proposed rule would make significant improvements to the safety reporting requirements for medicines. FDA has long collected and used information on adverse events to identify ways that drugs can be used more safely, and occasionally remove products from the market. But we can do better - we can get more useful and accurate information faster and more efficiently with the new regulation. Under the proposed rule, companies would be required to submit all reports they receive of actual and potential medication errors occurring in the United States to the FDA within 15 days. By expediting FDA's review and response to medication errors, the quick and complete reporting of these facts will improve patient safety and the ability of doctors to prescribe drugs in the best interest of their patients.

Companies would be required to submit all reports they receive of actual and potential medication errors occurring in the United States to the FDA within 15 days. By expediting FDA's review and response to medication errors, the quick and complete reporting of these facts will improve patient safety and the ability of doctors to prescribe drugs in the best interest of their patients.

But those new regulations are not the only good news about patient safety. I am privileged to make a second announcement this morning. Our Agency for Healthcare Research and Quality is launching new tool to enhance patient safety. These Patient Safety Indicators will help hospitals to quickly detect potential medical errors, so we can develop strategies to improve safety. The web-based tool uses secondary diagnostic codes to detect 26 types of adverse events. And that's something we can all look forward to.

The regulations and the diagnostic tool share a critical focus: preventing errors instead of compensating for them.

But let's talk about the compensation side, too. We all want to prevent medical errors. When they occur, we want to compensate patients fairly. But we also want to protect doctors and hospitals from another threat to quality care: frivolous lawsuits, and unnaturally high medical costs caused by those suits. As you know, medical liability premiums have skyrocketed in recent years as average jury awards have doubled from $475,000 in 1996 to $1 million in 2000.

This may lead to worse quality care because doctors practice defensive medicine - lawyers, not doctors, are influencing medical care. Even worse, it reduces access to care, because many physicians simply can't afford to practice.

This is a national problem that requires a national solution. After all, it costs the federal government $28 billion a year. The Bush Administration has a comprehensive reform proposal that will serve two goals.

The President and I have urged Congress to pass a bill that would put reasonable limits on subjective non-economic damages. This would emulate what the state of California did with great success 25 years ago. I did it in Wisconsin about 12 years ago. We also need to limit punitive damages in medical liability cases.

Under our proposal, injured patients would collect full actual, out-of-pocket damages - medical costs, lost wages, custodial care and assistance, or replacement child care for an injured mother, for example. But they would not be able to collect unlimited amounts for "non-economic" damages.

We support legislation that would also make key procedural reforms in medical liability cases: elimination of joint and several liability � uniform statute of limitations � collateral source rule reform � and reasonable limits and court approval of attorney contingency fees.

The House of Representatives passed these reforms last September, and will take them up again today. We call on the Senate to join us in bringing these common sense reforms to all Americans. Lawyers should not be driving good doctors out of business.

Another problem caused by fear of litigation is that doctors are often reluctant to discuss medical errors frankly. That's why we also strongly support Patient Safety Organization legislation.

By ensuring that information is kept confidential, this legislation encourages doctors, hospitals, and other experts to work together to improve quality. Under our proposal, Patient Safety Organizations would be able to examine procedures and outcomes at all hospitals and nursing homes and make suggestions for improvements.

Because they will receive information from more than one hospital and about more than one doctor, Patient Safety Organizations will be able to detect patterns of good and bad practices that might not otherwise be noticeable on a single provider basis. They will be able to make solid recommendations to local providers about improving their procedures.

I am pleased to report that, last night, the House of Representatives by a broad and bipartisan margin passed H.R. 663, the Patient Safety and Quality Improvement Act. This bill would provide peer review protection of information reported to patient safety organizations for the purposes of quality improvement and patient safety.

It would also establish a national database to analyze health care errors. We look forward to continuing to work with Members of Congress to secure enactment of such important patient safety legislation.

I know that many of you in this room are doctors, and you know how important these changes will be. You deserve the freedom to practice your profession and make decisions in your patients' best interests.

That means freedom from burdensome regulation, freedom from excessive lawsuits, and freedom to innovate in the interest of the health care their patients need. You became doctors because you want to heal people. I became Secretary of Health and Human Services to make sure government doesn't get in your way.

MEDICARE

But I hope Congress won't stop at patient safety. After years of watching Congress bemoan the state of Medicare but fail to rise above partisan bickering, I'm proud that President Bush has the courage to propose a bold plan to improve Medicare.

We want to improve the health of America's seniors-to make sure that every senior in the country gets meaningful new benefits, including help with prescription drugs.

As I said before, the greatest health care system the world has ever known operates in the United States. And you're a critical part of it. America's doctors and hospitals offer the best care because they enjoy the freedom to compete and Americans enjoy a choice of providers.

However, our Medicare program is not structured to provide seniors access to these wondrous inventions, new technology, and the same choices and quality other Americans get from their health plans. For example, while 76% of seniors have some form of drug coverage, Medicare itself does not provide an outpatient drug benefit, so too many seniors go without the medicines they need.

As President Bush has observed, Medicare will pay a doctor to perform a heart bypass operation, but will not pay for drugs that could prevent the need for surgery. Medicare will pay for an amputation, but not for the insulin that could help diabetes patients avoid losing their limbs.

President Bush wants to remove these barriers to affordable, quality health care by modernizing Medicare, for its current beneficiaries and for the future. That's why, last week, he proposed a framework to improve Medicare by offering more choices and better benefits. In order to make these changes, the President and I need Congress's help and your help.

In addition to meeting the projected growth of Medicare, the President proposes to spend an additional $400 billion over the next ten years to pay for these improvements. Medicare beneficiaries will be offered several types of coverage, including keeping what they have now, and all of these choices will include a subsidized prescription drug benefit.

Let me outline the three options that we will offer Medicare beneficiaries: Traditional Medicare, Enhanced Medicare, and Medicare Advantage.

• Traditional Medicare. This is the fee-for-service system Medicare participants currently enjoy. Our framework would add benefits including help with prescription drugs and protection from high out of pocket drug costs.
  
  
• Enhanced Medicare. This option would include:
• comprehensive drug coverage;
• full coverage for disease prevention;
• protection from high out-of-pocket costs for lengthy hospital stays;
• and the same types of health care choices and benefits that I get, and that members of Congress get.
  
  
• The third option is Medicare Advantage. This is the low-cost, high-coverage plan that many seniors currently receive and prefer. Under our framework, it includes a subsidized drug benefit.

So those are the three options. But it's also important to keep in mind what all three options have in common.

• All seniors will receive prescription drug assistance.
• All seniors will be able to choose doctors and hospitals.
• And all seniors will have the choice of an individual health care plan that best meets their needs-just like Members of Congress and federal employees have.

All of us want to make sure that Medicare does the right thing for seniors. And you know that seniors want better coverage. That's why it is urgent that Congress work with the President to modernize and improve Medicare this year. If these choices are good enough for members of Congress, they are good enough for our seniors.

I should mention that our framework also provides extra help for low-income seniors to cover their prescription drugs. This is in addition to the drug discount card we will offer to all seniors.

The sooner we act, the sooner we can offer the meaningful new benefits to all our seniors, and the healthier our citizens-and our economic future-will be.

MEDICAID

Reform of Medicare would be incomplete without reform of Medicaid. Most people don't realize that Medicaid is bigger than Medicare, and is growing more rapidly. Both are vital to making sure all Americans have access to health care.

Sadly, the current Medicaid system is a bureaucratic and fiscal mess. It's not delivering consistent results for the taxpayers' dollar, and it's proving a fiscal nightmare for the states.

Most states are facing a budget crisis right now. Because Medicaid is one of the largest items in a state budget, a state government facing budget pressure may have no choice but to look at Medicaid spending. Under the current matching mechanism, if a state cuts $1 of its own spending, it may forfeit $2 in federal funds.

That's why I'm happy to tell you that the Bush Administration has proposed a plan to make Medicaid more effective, cover more people, and provide better health care delivery.

If Congress adopts this plan, states will be able to improve health coverage for low-income Americans. Americans who might be cut off from coverage will be able to keep it.

We're going to begin by addressing the immediate fiscal needs of the states � meeting the 9% base growth in the program with adequate funding � and adding in another $3.25 billion in new money for 2004 and $8.9 billion in new money over five years. Our plan will be budget-neutral over ten years, but will frontload some of the money from the later years into the earlier years.

And we're going to give states the flexibility they need to spend that money. They must be able to tailor the spending to address their own areas of greatest need.

I spent fourteen years as Governor of Wisconsin, and let me tell you, states and their governors absolutely must have this freedom to act. Unfortunately, the bureaucratic rules of Medicaid today are too inflexible - but we're going to change that.

Finally, Medicaid reform means holding states to performance standards. We're going to make sure this money is spent wisely - children must be covered � fair benefits must be provided � and the rolls of the uninsured must come down. That's common-sense reform and common-sense leadership. And it's yet another way we're going to extend access to health care while keeping health care costs down.

I've outlined an ambitious agenda this morning: patient safety, medical liability, Medicare, and Medicaid. We could achieve any one of them and call it a good year. But all of them need our attention. We want a better system that gives better care to everyone. That's the American tradition.

Americans have made many great discoveries over the years, and the discoveries that will endure the longest have expanded our understanding of nutrition and exercise, birth and aging, and how to prevent, treat, and cure disease, disability, and suffering.

We have better knowledge and technology at our disposal than ever before. We have much more to discover, and at the same time we also have the opportunity to put our recent discoveries into practice - to make sure America's federal and state health programs, and the entire medical industry, reflect the best work of our researchers and the kindest impulses of our hearts.

Thank you.

Last Revised: March 13, 2003

HHS Home | Questions? | Contact HHS | Accessibility | Privacy Policy | FOIA | Disclaimers

The White House | USA.gov | Helping America's Youth

U.S. Department of Health & Human Services · 200 Independence Avenue, S.W. · Washington, D.C. 20201